Paroxetine in the Treatment of Chronic Primary Insomnia

NCT00178048 | Completed Phase 4

• 1 other identifier: 970357
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of the study is to examine the role of paroxetine, an antidepressant medication, in the acute and continuation treatment of insomnia. Primary insomnia is a type of insomnia not directly resulting from general medical, chemical, or psychiatric conditions.

Conditions

Primary Insomnia; Depression

Keywords

primary insomnia; insomnia; depression; late life; elderly; sleep disorders

Outcome Measures

Primary Outcomes (1)

• Paroxetine in combination with sleep hygiene therapy will produce a greater number of responders in acute treatment, compared to a placebo and sleep hygiene condition, in a randomized, double-blinded, six-week acute trial

Secondary Outcomes (9)

• Polysomnographic Sleep measures

• Pittsburgh Sleep Quality Index and Sleep Diary

• Daytime well being on the Profile of Mood States

• Daytime functioning on the Sickness Impact Profile, Medical Outcomes Study (SF-36), and UKU

• Stress measures: Schedule of Recent Events, Perceived Stress Scale, Impact of Life Events Scale, Ways of Coping Inventory, Multidimensional Fatigue Inventory, and Brief Symptom Inventory

Interventions

paroxetine DRUG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 or older
• Diagnosis of chronic primary insomnia
• Score of 8 or higher on the Pittsburgh Sleep Quality Index
• free of all antidepressants and benzodiazepine for two weeks

You may not qualify if:

• lifetime diagnosis of any psychotic disorder,or bipolar disorder.
• DSM-IV diagnosis of dysthymia or generalized anxiety disorder
• Diagnosis of major depression within the past 6 months
• Alcohol or drug abuse within the past 6 months
• Contraindication to SSRI therapy
• History of seizure disorder
• Baseline apnea/hypopnea index score greater than 15
• Hyponatremia

Sponsors & Collaborators

• University of Pittsburgh: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsubrgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Sleep Wake Disorders

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Charles F Reynolds III, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 1998
• Study Completion: December 1, 2003
• Last Updated: September 15, 2005

Record last verified: 2005-09

Locations

US (2)